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Ibogaine Protocol Page 1 of 26 Protocol 2/24/05 Exploratory outcome study of the long-term efficacy of Ibogaine-assisted therapy in participants with substance addiction 2/24/05 Principal Investigator: Valerie Mojeiko Sponsor: Multidisciplinary Association for Psychedelic Studies (MAPS) www.maps.org Page 2 of 26 Table of Contents Introduction............................................................................................................3 Hypotheses……………………………………………………………………………………………………………………………….4 Background.............................................................................................................4 Neurotransmitter Activities………………………………………………………………………………………………………5 Evidence of Efficacy………………………………………………………………………………………………………………….6 Subjective Effects in Humans.........………………………………………………………………………………………..8 Models of Action and Treatment Procedures……………………………………………………………………………9 Economic and Political Perspectives.......................................................…..................12 Study Design......................................................................................……...............14 Outcome Measures............................................................................................…….14 Data Collection and Analysis..…...................…..................……........….......................….16 Schedule of Outcome Measures.....................................................…….......................20 Appendix A: Clinic’s Inclusion and Exclusion Criteria for Treatment………………………………..….21 Appendix B: Iboga Therapy House Treatment Team……………………………………………………………..22 Appendix C: Surveys.........................................................................………………………..22 References.........................................................................…...........................……..23 Page 3 of 26 Introduction The current protocol is an exploratory outcome study of ibogaine-assisted therapy, a novel pharmacotherapeutic treatment, in participants with substance addictions. Participants will be 20 people treated sequentially at the Iboga Therapy House. Follow-up data will be gathered for one-year post treatment. This study is intended to gather preliminary evidence about whether ibogaine-assisted therapy can facilitate long-term recovery from chemical dependence. Ibogaine is a naturally occurring psychoactive plant alkaloid with a low potential for abuse. It is hypothesized that ibogaine halts or attenuates addiction through two processes, one pharmacological and one psychological. Its pharmacological component relieves the physical symptoms of opiate withdrawal, and this is augmented by a psychological component that causes the participants to re-assess his or her life. This study will analyze survey data from clients who undergo ibogaine treatment for substance addiction at the Iboga Therapy House in Vancouver, BC (www.ibogatherapyhouse.org), a clinic established in 2003 that administers ibogaine hydrochloride, a chemical extracted from the root bark of Tabernanthe Iboga, a shrub indigenous to West Africa and used in rituals by native populations. The clinic, which is temporarily closed due to lack of funding, treated a total of 31 people during its time of operation, from January 2003 to June 2004. This research project will analyze survey data collected through the Iboga Therapy House’s evaluation program. While ibogaine is a Schedule I drug in the US, it is not scheduled in Canada and is not the participants of any regulation or policy in Canada, thus the Iboga Therapy House administers ibogaine legally. The clinic offers a 5-day residential detoxification program, which includes preparation, one 24-36 hour-long ibogaine session, and post-session integrative work. A one-year evaluation program conducted through telephone calls with the facility’s evaluation coordinator follows the in-clinic program. The Addiction Severity Index (ASI) is the primary questionnaire that is used to determine outcome data within the study. It is administered at monthly intervals for a period of one year post-treatment to quantitatively measure changes in participants’ drug use and lifestyle before and after the ibogaine session. It is supplemented with additional questions relevant to this particular treatment in the form of client and clinician surveys. The outcome coordinator will also be in contact with a significant other to verify the truthfulness of the client’s information. The Self-Identity Survey (SIQ-SR) is a self-report measure of the degree to which an individual with a substance dependence views him or herself as belonging to a number of pertinent roles. The measure contains four sub-scales; Addict, Recovery, Work, Family, and Religion, with religion sub-divided into “Organized Religion” and “Spirituality.” A copy of the measure and a scoring form were provided by the author. The Peak Experience Profile is administered once after treatment to gauge the depth of peak and nadir experience during the ibogaine treatment. The Beck Depression and Anxiety Inventories are administered to measure fluctuations in depression and anxiety before and after treatment. Physical pain and withdrawal symptoms are monitored with the Subjective and Objective Opiate Withdrawal Scales and with a one to ten-point pain rating scale. If this study generates promising results, work will be initiated on designing a randomized, double-blind, placebo-controlled study Page 4 of 26 Changes in addiction-related behavior, mood and quality of life will be explored, and the following hypotheses concerning outcome of ibogaine treatment will be tested. Hypotheses Primary Hypotheses: 1. Ibogaine-assisted therapy will result in decreases in average post-treatment scores on the Addiction Severity Index, with scores averaged over a one-year period. 2. Ibogaine-assisted therapy will result in extended periods of abstinence post- treatment as quantified by average number of days post-treatment without use of problem drug, and also by average time to first relapse (use of problem drug, whether controlled or not). Secondary Hypotheses: 1. Decreases in the Addiction Severity Index post-treatment will be correlated with high scores in both nadir and spiritual experiences as measured by the Peak Experience Profile. 2. Ibogaine-assisted therapy will result in decreases in average post-treatment scores on the Beck Depression Inventory and Beck Anxiety Inventory. 3. Decreases in the Addiction Severity Index post-treatment will be correlated with decreases in the Beck Depression Inventory and Beck Anxiety Inventory. 4. Ibogaine-assisted therapy will result in decreases in the Objective Opiate Withdrawal Scale and Subjective Opiate Withdrawal Scale immediately after treatment. 5. Ibogaine-assisted therapy will result in extended periods of abstinence plus extended periods of controlled drug use as quantified by amount of drugs used, and method and schedule of administration relevant to baseline. 6. Average post-treatment scores of Addict Identity measured by the SIQ-SR will be lower than pre-treatment scores. 7. Average post-treatment scores of Work, Recovery, Family, and Religious Identity measured by the SIQ-SR will be higher than pre-treatment scores. Background Ibogaine, a naturally occurring plant alkaloid with a history of use as a medicinal and ceremonial agent in West Central Africa, has been alleged to be effective in the treatment of drug abuse. The National Institute on Drug Abuse (NIDA) has given significant support to animal research, and the U.S. Food and Drug Administration (FDA) has approved a Phase I study in humans which has not been completed due to lack of funding. Evidence for ibogaine's effectiveness includes a substantial preclinical literature on reduced drug self-administration and withdrawal in animals and case reports in humans. Ibogaine is of interest because it appears to have a novel mechanism of action distinct from other existing pharmacotherapeutic approaches to addiction, and it could potentially provide a paradigm for understanding the neurobiology of addiction and the development of new treatments. There is relatively little financial incentive for its development by the pharmaceutical industry because ibogaine is isolated from a botanical source in which it Page 5 of 26 naturally occurs, and its chemical structure cannot be patented. This has left the academic community and the public sector with a crucial role in research on ibogaine. Chemical Structure and Properties Ibogaine (10-methoxyibogamine) (Figure 1) is an indole alkaloid with molecular formula C20H26N2O and molecular weight 310.44. Ibogaine is the most abundant alkaloid in the root bark of the Apocynaceous shrub Tabernanthe iboga, which grows in West Central Africa. In the dried root bark, the part of the plant in which alkaloid content is highest, total alkaloid content is reportedly 5 to 6% (Pope 1969). Neurotransmitter Activities The pharmacology of ibogaine is complex and probably involves action at multiple neurotransmitter systems and interactions between one or more neurotransmitter system (Alper 2001; Popik and Skolnick 1999; Sweetnam et al. 1995). Evidence supports action as an NMDA antagonist and a mu opioid receptor antagonist. While data is sometimes contradictory, ibogaine probably acts as a kappa opioid agonist, a serotonin 5HT2A agonist, a serotonin uptake inhibitor, a 5HT3 agonist, a dopamine uptake inhibitor, and a sigma opioid receptor agonist (Alper 2001). There is some data supporting action on secondary messenger systems for mu opioid
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